Lybalin

Lybalin

pregabalin

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Central & peripheral neuropathic pain in adults including diabetic peripheral neuropathy & postherpetic neuralgia. Adjunct in adults w/ partial seizures w/ or w/o secondary generalizations. Generalized anxiety disorders (GAD) in adults. Management of fibromyalgia.
Dosage/Direction for Use
Neuropathic pain Initially 150 mg daily. May be increased to 300 mg daily w/in 1 wk. Max: 600 mg daily after additional 7 days interval (300 mg in diabetic peripheral neuropathy). Epilepsy Initially 150 mg daily (75 mg bid or 50 mg tid). May be increased to 300 mg daily after 1 wk. Max: 600 mg daily after additional wk. GAD Initially 150 mg daily in 2-3 divided doses. May be increased to 300 mg daily after 1 wk & further increased to 450 mg daily after additional wk. Max: 600 mg daily after additional wk. Fibromyalgia Initially 150 mg daily (75 mg bid). May be increased to 300 mg daily (150 mg bid) w/in 1 wk. Max: 450 mg daily (225 mg bid). Patients w/ insufficient benefit w/ 300 mg daily May be increased to max of 450 mg daily (225 mg bid). Renal impairment w/ CrCl 30 to <60 mL/min Initially 75 mg daily in 2 or 3 divided doses. Max: 300 mg daily in 2 or 3 divided doses, 15 to <30 mL/min Initially 25-50 mg in once daily or in 2 divided doses. Max: 150 mg in once daily or in 2 divided doses, <15 mL/min Initially 25 mg once daily. Max: 75 mg once daily. Patients undergoing hemodialysis receiving 75 mg once daily dose Supplemental dose of 100 mg or 150 mg, 50-75 mg once daily dose Supplemental dose of 75 mg or 100 mg, 25-50 mg once daily dose Supplemental dose of 50 mg or 75 mg, 25 mg once daily dose Supplemental dose of 25 mg or 50 mg.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if symptoms of angioedema & hypersensitivity reactions; myopathy or markedly elevated creatine kinase levels occur. W/draw gradually in patients w/ seizure disorders. Abrupt or rapid discontinuation. Hematologic disorder; peripheral edema; wt gain; decreased platelet count; PR interval prolongation. Previous episode of angioedema. Patients taking other drugs associated w/ angioedema. Monitor for worsening of depression, suicidal thoughts or behavior &/or unusual mood or behavior changes. Consider further assessment if visual disturbance persists. Liver & kidney disease. May impair ability to drive or operate machinery. Not to be used during pregnancy. Lactation.
Adverse Reactions
Abnormal coordination, gait &  thinking, amnesia, anxiety, asthenia, ataxia, attention disturbance, balance disorder, confusion, depersonalization, depression, disorientation, dizziness, dysarthria, erectile dysfunction, euphoria, headache, hypertonia, hypesthesia, incoordination, irritability, lethargy, decreased libido, memory impairment, myasthenia, myoclonus, nervousness, neuropathy, paresthesia, somnolence, speech disorder, stupor, tremor, twitching, vertigo; pruritus; abdominal distention & pain, constipation, diarrhea, dry mouth, flatulence, gastroenteritis, nausea, vomiting; ecchymosis; edema, face & peripheral edema, fluid retention, hypoglycemia, increased appetite, wt gain; abnormal & blurry vision, conjunctivitis, diplopia, eye disorder, nystagmus, otitis media, tinnitus; arthralgia, back pain, leg cramps, muscle spasms, myalgia, pain; bronchitis, pharyngolaryngeal pain, sinusitis; anorgasmia, impotence, urinary frequency & incontinence; accidental injury, allergic reaction, chest pain, dyspnea, fatigue, abnormal feeling, feeling drunk, fever, flu syndrome, infection.
Drug Interactions
Additive cognitive effect & gross motor functioning w/ CNS depressants eg, ethanol, lorazepam, oxycodone. Increased risk of angioedema w/ ACE inhibitors. Slightly decreased absorption w/ gabapentin. Additive effect on edema & wt gain &/or fluid retention w/ thiazolidinedione.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain / Antipsychotics
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Lybalin cap 25 mg
Packing/Price
56's
Form
Lybalin cap 75 mg
Packing/Price
56's
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